Femtosecond Laser Assisted Cataract Surgery in The NHS

NCT ID: NCT02825693

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-06-30

Brief Summary

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This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).

Detailed Description

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Conditions

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Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femtosecond laser cataract surgery

Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation

Group Type ACTIVE_COMPARATOR

Femtosecond laser assisted cataract surgery

Intervention Type PROCEDURE

Conventional phacoemulsification surgery

Conventional phacoemulsification surgery

Group Type ACTIVE_COMPARATOR

Conventional cataract surgery (phacoemulsification)

Intervention Type PROCEDURE

Interventions

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Conventional cataract surgery (phacoemulsification)

Intervention Type PROCEDURE

Femtosecond laser assisted cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
* Patients must be willing to attend for follow-up at 1 month after cataract surgery.
* Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.

Exclusion Criteria

* Children below the age of 18
* Already enrolled in another study


* Significant corneal opacities
* Small pupils following pharmacological dilatation
* Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ILH297-P002

Identifier Type: -

Identifier Source: org_study_id

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